DELIVERY DEVICE SYSTEM FOR SCLERAL CROSS LINKING (#2020019)

Background

Myopia (short sightedness) is a common refractive state of the eye that is usually caused by elongation of the eyeball. For obtaining sharp vision, myopes use glasses or contact lenses or undergo refractive surgery. However, the optical correction is not treating the morbidity associated with the increased axial length of the eye that can lead to structural changes in the retina and optic disc, particularly in high myopia. The stretched retina over the enlarged eyeball in high myopia (> -6 diopters) is associated with a significant risk of developing visual complications, including myopic macular degeneration, glaucoma, retinal detachment and for visual loss. Myopic chorioretinal degeneration is the 4th most frequent cause of blindness leading to visual services and disability registration, and accounts for 8.8% of all causes of blindness.

The standard goal of treating nearsightedness is to improve vision by helping focus light on the retina through the use of corrective lenses or refractive surgery to reduces the need for eyeglasses and contact lenses.

Managing nearsightedness also includes regular monitoring for complications of the condition, including glaucoma, cataracts, retinal tears and detachments, and damage to central retinal areas.

The Need

Nearly half of the global population may be nearsighted By 2050.

Is there a cure for nearsightedness? A number of recent studies suggest it may indeed be possible to at least control myopia by slowing its progression during childhood and among teenagers.

Currently, four types of treatment are showing promise for controlling myopia:

• Atropine eye drops
• Multifocal contact lenses
• Orthokeratology ("ortho-k")
• Multifocal eyeglasses

Atropine has unfavorable side effects, including photophobia and blurred vision while performing near work, thus reducing patient compliance.

Optical correction, including contact lenses, can also slow the progression of myopia; however, these approaches are generally less effective than atropine.

Orthokeratology is the use of specially designed gas permeable contact lenses that are worn during sleep at night to temporarily correct nearsightedness and other vision problems so glasses and contact lenses aren't needed during waking hours. The use of "ortho-k" lenses to also control myopia progression in children but is also less effective.

The global myopia and presbyopia treatment market size valued at USD 15.5 billion in 2018 and is expected to grow at a compound annual growth rate (CAGR) of 7.7% from 2019 to 2026. Increasing cases of vision loss largely due to myopia coupled with rising incidence of distance vision impairment due to uncorrected myopia, are some of the major factors expected to drive the growth.

The Innovation

We have developed a novel device to enable crosslinking of the sclera. 

We believe that this novel procedure will limit the excessive axial enlargement of the globe in degenerative myopia, that occurs preferentially in the posterior pole and mainly prevails at the younger age (<16).

Scleral cross-linking is predicted to mimic the natural stiffening of the sclera (and cornea) at an older age (>25), that is triggered by natural enzymatic crosslinking to arrest the elongation of the eye.

Therefore, it is hypothesized that ocular enlargement and consequently, degenerative myopia, can be prevented by scleral crosslinking and stiffening by light induced radicals formation.

Our innovative device main objective is to deliver photosensitizers and cross-linkers directly into the sclera in ONE DEVICE, guarantying adequate impregnation with minimal drug volume without spillage into the periocular tissues and associated risk.

Advantages

1. Adequate impregnation with minimal drug volume guarantees:
   • Controlled dosage
   • Location predetermined
   • Without spillage into the periocular tissues and associated risk
2. Light delivery – via fiber-optics for:
   • Precise to the injected area more controlled
   • Less luminance
   • Less retinal light exposure 
3. Possible use for other treatment and indications.

Potential Applications

1. A system for myopia treatment
2. Injectable Tissue Repair – in ocular AND non-ocular tissues 
3. Glaucoma surgery
4. Cross liking of implants for sustained drug release and delivery for posterior segment
5. Miniaturized versions of trabeculectomy
6. Trabecular bypass operations
7. Totally internal or suprachoroidal shunts
8. Milder, gentler versions of laser photocoagulation
9. Phototherapy – e.g. chemotherapy activated by light
10. Light for injection guidance

IP Status - Pending

The Market

The prevalence of myopia and high myopia is on the rise across the world.  Recent work from the Brien Holden Vision Institute estimates that the prevalence of myopia (≤ -0.50 D) will increase world-wide, from 28% (2 billion) of the global population in 2010, to nearly 50% (5 billion) of the world population by 2050. As a consequence, the prevalence of high myopia (≤ -5.00D) is also likely to increase from 4% (277 million) in 2010, to nearly 10% (1 billion) by the year 2050.

This may have important implications for planning comprehensive eye care services, including refractive ser­vices such as spectacles and contact lenses for correcting and slowing myopia progression. Optical and environmental interventions can help in preventing and managing high myopia related ocular complications and reduce the burden of myopia.

The shift towards myopia has been rapid in some parts of the world, such as the USA where the prevalence of myopia increased from 26% to 42% from 1972 to 2004. In Singapore, the prevalence of myopia was 47% in adults in their 20s, and 26% in adults in their 50s.

High myopia (≤ - 7.90 D) in the USA has already increased 8-fold over 30 years from 0.2% to 1.6%. In 18 year old Taiwanese students, 21.0% had high myopia (≤ -6.00 D) in 2000 compared with 10.9% in 1983.

Globally in 2000, most people with myopia were below age 40, and little myopia was seen in those over 40. By 2030, the prevalence of myopia is approximately 50% for all age groups above 20 years, and by 2050, it is up to 68% . Regions with traditionally little myopia, such as Eastern Europe and Southern Africa will also see a large shift towards myopia in the near future, approaching prevalence's of 50% and 30% by 2050 and is likely due to lifestyle changes as a result of urbanization and development. 

The global myopia and presbyopia treatment market size is expected to reach USD 28 billion by 2026, according to a new report by Grand View Research, Inc. It is projected to expand at a CAGR of 7.7% during the forecast period.

The global Myopia and Presbyopia Treatment market is highly competitive and consists of a number of major players. Companies like ALCON Inc., Bausch Health Companies Inc, EssilorLuxottica (Essilor Ltd.), Johnson & Johnson Vision, NIDEK CO. LTD., Topcon Corporation, Zeimer Ophthalmic Systems AG, ZEISS